Autologous Bone Marrow Derived Stem Cells for Acute Myocardial Infarction
NCT ID: NCT01167751
Last Updated: 2016-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
90 participants
INTERVENTIONAL
2008-01-31
2012-07-31
Brief Summary
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One therapeutic method is cellular cardiomyoplasty, which is to produce and substitute the cardiac cells with stem cell transplantation. Cell therapy is a potential therapeutic method to prevent ventricular remodeling after acute myocardial infarction. Human and animal studies have shown that stem cell trans plantation to myocardial infarcted zone can improve heart contractile function.
The aim of this study is to comparison the effects of BM-derived AC133 and MNC implantation in patients with myocardial infarction.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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MNC implantation
Implantation of BM derived MNC
MNC
Implantation of BM derived MNC
AC 133 implantation
Implantation of BM derived AC 133
AC 133
Implantation of BM derived AC133
Control
Injection of cell carrier
Control
Injection of cell carrier
Interventions
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MNC
Implantation of BM derived MNC
AC 133
Implantation of BM derived AC133
Control
Injection of cell carrier
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 4 akinetic segments
* First anterior heart attack within in 10 days to 3 month.
* St elevation MI defined by: Post Acute MI LVEF less than 45% as assessed by echocardiography.
* The target lesion had to be located in the left anterior descending (LAD) section.
Exclusion Criteria
* History of prior CABG
* Poor echocardiography window.
* Active infection or history of recurrent infection or positive test for syphilis (RPR), hepatitis B and C (HBSAg/ Anti HBc Anti - Hcv) HIV and HTLV-l
* Documental terminal illness or malignancy.
* Previous bone marrow transplant
* Autoimmune disease (e. g Lupus, Multiple sclerosis)
* Any contraindication for bone - marrow aspiration.
* Positive pregnancy test (in women with child bearing potential)
18 Years
75 Years
ALL
No
Sponsors
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Royan Institute
OTHER_GOV
Responsible Party
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Principal Investigators
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Hamid Gourabi, PhD
Role: STUDY_CHAIR
Royan Institute
Hossein Baharvand, PhD
Role: PRINCIPAL_INVESTIGATOR
Royan Institute
Mohammadhassan Nasseri, MD
Role: PRINCIPAL_INVESTIGATOR
Baghiatollah
Nasser Aghdami, MD, PhD
Role: STUDY_DIRECTOR
Royan Institute
Locations
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Royan Institute
Tehran, Tehran Province, Iran
Countries
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References
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Ahmadi H, Baharvand H, Ashtiani SK, Soleimani M, Sadeghian H, Ardekani JM, Mehrjerdi NZ, Kouhkan A, Namiri M, Madani-Civi M, Fattahi F, Shahverdi A, Dizaji AV. Safety analysis and improved cardiac function following local autologous transplantation of CD133(+) enriched bone marrow cells after myocardial infarction. Curr Neurovasc Res. 2007 Aug;4(3):153-60. doi: 10.2174/156720207781387141.
Naseri MH, Madani H, Ahmadi Tafti SH, Moshkani Farahani M, Kazemi Saleh D, Hosseinnejad H, Hosseini S, Hekmat S, Hossein Ahmadi Z, Dehghani M, Saadat A, Mardpour S, Hosseini SE, Esmaeilzadeh M, Sadeghian H, Bahoush G, Bassi A, Amin A, Fazeli R, Sharafi Y, Arab L, Movahhed M, Davaran S, Ramezanzadeh N, Kouhkan A, Hezavehei A, Namiri M, Kashfi F, Akhlaghi A, Sotoodehnejadnematalahi F, Vosough Dizaji A, Gourabi H, Syedi N, Shahverdi AH, Baharvand H, Aghdami N. COMPARE CPM-RMI Trial: Intramyocardial Transplantation of Autologous Bone Marrow-Derived CD133+ Cells and MNCs during CABG in Patients with Recent MI: A Phase II/III, Multicenter, Placebo-Controlled, Randomized, Double-Blind Clinical Trial. Cell J. 2018 Jul;20(2):267-277. doi: 10.22074/cellj.2018.5197. Epub 2018 Mar 18.
Related Links
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Related Info
Other Identifiers
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Royan-Heart-001
Identifier Type: -
Identifier Source: org_study_id
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